A Dose-Ranging Study to Determine the Efficacy, Safety and Tolerability of AeroFact
Purpose
The purpose of this two-part Phase 2 study is to assess the safety, tolerability and efficacy of aerosolized SF-RI 1 (AeroFact) when delivered via nCPAP at two different doses.
Condition
- Respiratory Distress Syndrome in Premature Infant
Eligibility
- Eligible Ages
- Between 26 Weeks and 31 Weeks
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Parental consent obtained prior to study procedures being performed (pre-natal consent is allowed) 2. 26 0/7 to 30 6/7 weeks of gestational age 3. Weight <2.0 Kg 4. Respiratory Severity Score (RSS) 1.4-2.0
Exclusion Criteria
- Apgar score less than or equal to 5 at five minutes after birth 2. Need for chest compressions or administration of epinephrine or bicarbonate in the delivery room 3. Premature rupture of membranes (PROM) > 14 days 4. Need for intubation and/or mechanical ventilation prior to enrollment 5. Active pneumothorax requiring chest tube 6. Significant congenital anomaly, chromosomal abnormality 7. Concomitant treatments with inhaled nitric oxide
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Partially Blinded, Randomized, Parallel-Group Dose Ranging
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Masking within active arms
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other nCPAP alone |
Standard of Care (nasal continuous positive airway pressure-nCPAP) with instilled bolus surfactant when medically necessary |
|
|
Experimental Drug: Low Dose AeroFact |
AeroFact-low dose SF-RI 1 |
|
|
Experimental Drug: High Dose AeroFact |
AeroFact-high dose SF-RI 1 |
|
Recruiting Locations
More Details
- NCT ID
- NCT03969992
- Status
- Active, not recruiting
- Sponsor
- Aerogen Pharma Limited
Detailed Description
Part I Primary Objective To determine an optimal dose of AeroFact administered by nasal continuous positive airway pressure (nCPAP) versus stand of care in reducing the rate of intubation/cannulation and bolus surfactant instillation in the first 7 days after birth. Part II Primary Objective To evaluate pulmonary outcomes and respiratory utilization at 3, 6, 9, and 12 months post-menstrual age (PMA)